[Innovative Medicine] R&D, Director, Regulatory Development, Regulatory Affairs

At Johnson & Johnson, we believe health is everything.

Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:
Discovery & Pre-Clinical/Clinical Development

Job Sub Function:
Regulatory Science

Job Category:
People Leader

All Job Posting Locations:
Chiyoda, Tokyo, Japan

Job Description:

JOB SUMMARY:


* Directs, drives and manages the activities of Regulatory Development Department (RDD) to successfully achieve the development and get approvals of drugs led by Regulatory Compound Leaders (RCL) with their Managers


* Responsible for the compliance of the department with all relevant laws, regulations, guidelines, policies and procedures.


* Negotiate or contact with Japanese Health Authorities (HA) and global regulatory affairs (GRA) to support the RCL and the ROps and the other department about the issue related to R&D

KEY RESPONSIBILITIES:


* Supervises and oversees the activities of the RCL to successfully achieve the development and get approvals of drugs.


* Ensures that all activities of the RCL are in compliance with regulations, credo, compliance policies and SOP/procedures/manuals.


* Contacts with HA and GRA/ APRA regulatory to support the RCL and JDT


* Contact with HA and GRA/ APRA regulatory about the non-project regulatory issues


* Support proactively the activities of the regulatory policy intelligence in Japan


* Reviews and provides regulatory input on CTD, Briefing book and the other documents which are submitted to HA.


* Represents RDD in the R&D governance and processes


* Manages the interface between RDD and other departments, in particular on non-product related issues, on multiple-product issues beyond a single product, and on portfolio issues


* Establishes and fosters good working relationship within RDD, with other functional departments within Japan R&D, GRA/APRA.


* Takes responsibility for the preparation of yearly budget and financial targets.


* Monitors, budgets and controls expenditure within established budgets.


* Recruits, develops, and retains a diverse workforce of excellent individuals in RDD.


* Promotes innovation and creativity, and stimulates individuals of RCL to propose flexible and breakthrough regulatory strategy

REQUIREMENTS:

Experience/Knowledge


* Generally requires (more than 5) years related experience


* Skills/Capabilities

Qualification/Certificate


* Master’s degree or Equivalent

REPORTING RELATIONSHIPS:


* Report to Head of Regulatory Affairs Division

＜Fo...